Regeneron Wins FDA Approval for Blindness Drug Eylea

Nov. 18 (Bloomberg) -- Regeneron Pharmaceuticals Inc. won
U.S. approval of Eylea, a treatment for a common cause of
blindness that will rival Roche Holding AG’s Lucentis.

The Food and Drug Administration cleared the injection to
treat wet age-related macular degeneration, a leading cause of
vision loss in people 60 and older, the company said in a
statement today. The drug will hit peak sales of $1.1 billion in
2021 as its use is expanded to other eye disorders, said Yaron
Werber, an analyst for Citigroup Inc. in New York.

Eylea can be injected every eight weeks, half as often as
Basel, Switzerland-based Roche’s Lucentis. Less frequent dosing
may help Eylea capture 16 percent of the U.S. market from
Lucentis, Werber said in a telephone interview before the
approval was announced.

“We think doctors want to experiment with the drug and
there’s a lot of interest,” he said.

Eylea will cost about $1,850 per dose or $16,000 for a
year’s treatment, said Robert Terifay, senior vice president for
commercial, during a conference call. The drug will be available
for doctors to order Nov. 21 and delivered by the next day, he
said.

Lucentis, which has about 40 percent of the market, is
$2,000 for each monthly injection. Doctors also use Roche’s
Avastin, approved to treat certain cancers, on about 60 percent
of wet age-related macular degeneration patients. It costs about
$50 per injection and is the subject of federal safety reviews
after being linked to eye infections.

Lucentis generated $1.4 billion in sales last year.

Earlier Delay

The FDA initially delayed its decision on Aug. 16 saying
that answers Regeneron provided to the agency on its application
about manufacturing controls were “a major amendment.”

Age-related macular degeneration is a breakdown of the
eye’s macula, the part of the eye that allows people to see fine
detail needed to do tasks such as reading and driving. In the
wet form of the disease, there is abnormal growth of blood
vessels that can leak fluid into the macula, leading to vision
loss.

Regeneron estimates about 1.5 million people have the wet
form of the disease with 200,000 new cases diagnosed each year.
Regeneron, based in Tarrytown, New York, fell 2.6 percent to
$49.81 at 4 p.m. New York time, before the approval was
announced.